Three-year Follow-up Study of Subjects Who Participated in a Previous Lambda (BMS-914143) Chronic Hepatitis C Clinical Trial

The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with BMS-914143 and achieved sustained virologic response

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution, Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects must have received Lambda in a previous trial and have Hepatitis C virus (HCV) Ribonucleic acid (RNA) < LOQ at the completion of the required post-treatment follow-up (must enter this study within 6 months of completion of the required post-treatment follow-up in the previous trial) NOTE: For blinded parent trials, subjects who have HCV RNA <LOQ at the completion of the required post-treatment follow-up may enter this study without knowledge of their treatment assignment in the parent study. Subjects who received control agents (eg, pegylated-interferon alfa) in the previous protocol will be allowed to participate until unblinded treatment information is released; at that time subjects will have the option to continue in the study

Exclusion criteria

Subjects must not have been treated with any antiviral or immunomodulatory drug for chronic hepatitis C after completion of the previous study of Lambda

Treatment and study plan

Peginterferon Lambda-1a (BMS-914143)

Drug

Observational study - No Intervention [subjects were previously treated with Peginterferon Lambda-1a (BMS-914143)]

Primary outcomes

Durability of virologic response (time to loss of virologic response)

Time frame: 24 week intervals from end of treatment in parent study up to 144 weeks

Durability of virologic response as assessed by the time to loss of virologic response in subjects treated in a previous study with BMS-914143 who have HCV RNA less than the limit of quantitation of the assay (< LOQ) at the completion of the required post-treatment follow-up in the previous study. Loss of virologic response assessed using HCV RNA at 24-week intervals

Secondary outcomes

Long-term progression of liver disease

Time frame: 24 week intervals up to 144 weeks

Long-term progression of liver disease as measured by laboratory indicators of hepatic status and function, all-cause mortality and liver related mortality in subjects previously treated with BMS-914143 who have HCV RNA < LOQ at the completion of the required post-treatment follow-up in the parent study
Duration of persistence of anti-Lambda antibodies in subjects who are positive for anti-Lambda antibodies at end of treatment in the parent study

Time frame: 24 week intervals up to 144 weeks

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Long-Term Follow-Up Study of Subjects Who Participated in a Clinical Trial in Which Peginterferon Lambda-1a (BMS-914143) Was Administered for the Treatment of Chronic Hepatitis C

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Feb 3, 2012
Registry last updated: Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed